UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report: (Date of earliest event reported): January 3, 2012 (January 3, 2012)
CELL THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
Washington | 001-12465 | 91-1533912 | ||
(State or other jurisdiction of incorporation or organization) |
(Commission File Number) |
(I.R.S. Employer Identification Number) |
501 Elliott Avenue West, Suite 400
Seattle, Washington 98119
(Address of principal executive offices)
Registrants telephone number, including area code: (206) 282-7100
Not applicable
(Former name or former address, if changed since last report).
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 7.01 | Regulation FD Disclosure. |
A copy of Cell Therapeutics, Inc.s (the Company) press release, entitled FDAs Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012 is furnished and not filed pursuant to Item 7.01 as Exhibit 99.1 hereto. Such information shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, and shall not be deemed to be incorporated by reference into any of the Companys filings under the Securities Act of 1933, as amended, or the Exchange Act whether made before or after the date hereof and regardless of any general incorporation language in such filings, except to the extent expressly set forth by specific reference in such a filing.
Item 8.01 | Other Events. |
On January 3, 2012, the Company announced that on February 9, 2012 the U.S. Food and Drug Administrations Oncologic Drugs Advisory Committee will review the resubmitted New Drug Application for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkins lymphoma.
Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
Exhibit Number |
Description | |
99.1 |
Press Release, dated January 3, 2012, entitled FDAs Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012. |
SIGNATURE
Pursuant to the requirements of the Exchange Act, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
CELL THERAPEUTICS, INC. | ||||||
Date: January 3, 2012 | By: | /S/ JAMES A. BIANCO, M.D. | ||||
James A. Bianco, M.D. | ||||||
Chief Executive Officer |
EXHIBIT INDEX
Exhibit Number |
Description | |
99.1 | Press Release, dated January 3, 2012, entitled FDAs Oncologic Drugs Advisory Committee to Review Resubmitted Pixantrone New Drug Application on February 9, 2012. |
Exhibit 99.1
|
www.CellTherapeutics.com |
FDAs Oncologic Drugs Advisory Committee to Review
Resubmitted Pixantrone New Drug Application on February 9, 2012
SEATTLE, January 3, 2012Cell Therapeutics, Inc. (CTI) (Nasdaq and MTA: CTIC) announced today that on February 9, 2012 the U.S. Food and Drug Administrations (FDA) Oncologic Drugs Advisory Committee (ODAC) will review CTIs resubmitted New Drug Application (NDA) for pixantrone for the treatment of relapsed or refractory aggressive non-Hodgkins lymphoma (NHL) in patients who failed two or more lines of prior therapy. ODAC is a panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational products for use in the treatment of cancer and makes recommendations to the FDA. The FDA will consider the recommendation of the panel, but the final decision regarding the approval of the product is made by the FDA.
We are pleased the Office of Oncology Drug Products (OODP) chose to bring our pixantrone NDA back to ODAC for review now that we have provided additional information and data recommended by the Office of New Drugs (OND) that we believe addresses the issues raised in the OODP Complete Response Letter of April 2010, stated James A. Bianco, CEO of CTI. We believe the NDA demonstrates that pixantrone has a favorable benefit risk profile compared to standard chemotherapy in patients with relapsed or refractory aggressive NHL, a patient population for which there are no approved agents.
About Pixantrone
Pixantrone is a novel aza-anthracenedione that has distinct structural and physio-chemical properties that make its anti-tumor activity unique in this class of agents. Similar to anthracyclines, pixantrone inhibits Topo-isomerase II but unlike anthracyclines rather than intercalation with DNA pixantrone alkylates DNA forming stable DNA adducts with particular specificity for CpG-rich, hyper-methylated sites. These structural differences resulted in significantly enhanced anti-lymphoma activity compared to doxorubicin in preclinical models. In addition, the structural motifs on anthracycline-like agents that are responsible for the generation of oxygen free radicals and the formation of toxic drug-metal complexes have also been modified in pixantrone in an effort to prevent the binding of iron and perpetuation of
501 Elliott Ave. W. #400 Seattle, WA 98119 |
T 206.282.7100 F 206.284.6206 |
Page 2 of 3
superoxide production both of which are the putative mechanism for anthracycline induced acute cardiotoxicity. These novel pharmacologic differences may allow re-introduction of anthracycline-like potency in the treatment of relapsed/refractory diffuse large lymphoma without unacceptable rates of cardiotoxicity.
About Cell Therapeutics, Inc.
Headquartered in Seattle, CTI is a biopharmaceutical company committed to developing an integrated portfolio of oncology products aimed at making cancer more treatable. For additional information, please visit www.CellTherapeutics.com http://www.CellTherapeutics.com.
Sign up for email alerts and get RSS feeds at our Web site,
http://www.CellTherapeutics.com/investors_alert
This press release includes forward-looking statements that involve a number of risks and uncertainties the outcome of which could materially and/or adversely affect actual future results and the market price of CTIs securities. Specifically, the risks and uncertainties that could affect the development of pixantrone include risks associated with preclinical and clinical developments in the biopharmaceutical industry in general, and with pixantrone in particular, including, without limitation, the potential failure of pixantrone to prove safe and effective for the treatment of relapsed or refractory NHL and/or other tumors as determined by the FDA and/or the EMA, that accelerated approval by the FDA of pixantrone may not occur, that CTI may not be able to address satisfactorily the two key matters raised by the OND or other matters raised by the FDAs Division of Oncology Products 1 (DOP1), the OND and/or the FDA, that CTIs interpretation of the guidance provided by the OND, the DOP1 and/or the FDA may be different than the intent of the OND, the DOP1 and/or the FDA, that the OND, the DOP1 and/or the FDA may change its guidance, that the PIX301 study may not be deemed successful, that upon a re-review and/or resubmission of the NDA the FDA may find pixantrone to not be safe and/or effective, that the PIX301 study may still be deemed to be a failed study, that the FDA may require an additional clinical trial of pixantrone, that if CTI conducts an additional clinical trial, it may not demonstrate the safety and effectiveness of pixantrone, that CTI may not be able to provide satisfactory information in response to the FDAs Complete Response Letter, that ODAC may not review the NDA on February 9, 2012, that CTI cannot guarantee that ODACs review of the NDA will result in a favorable recommendation to the FDA, that the FDA may not follow ODACs recommendation regarding the NDA, CTIs ability to continue to raise capital as needed to fund its operations, competitive factors, technological developments, costs of developing, producing and selling pixantrone, and the risk factors listed or described from time to time in CTIs filings with the Securities and Exchange Commission including, without limitation, CTIs most recent filings on Forms 10-K, 10-Q and 8-K. Except as may be required by law, CTI does not intend to update or alter its forward-looking statements whether as a result of new information, future events, or otherwise.
501 Elliott Ave. W. #400 Seattle, WA 98119 |
T 206.282.7100 F 206.284.6206 |
Page 3 of 3
Media Contact:
Dan Eramian
T: 206.272.4343
C: 206.854.1200
E: deramian@ctiseattle.com
Investors Contact:
Ed Bell
T: 206.272.4345
Lindsey Jesch Logan
T: 206.272.4347
F: 206.272.4434
E: invest@ctiseattle.com
www.CellTherapeutics.com/investors
Medical Information Contact:
T: 800.715.0944
E: info@askarm.com
501 Elliott Ave. W. #400 Seattle, WA 98119 |
T 206.282.7100 F 206.284.6206 |